2016年10月12日星期三

HKCTC Seminar on Professional Integrity in Testing and Certification

The Hong Kong Council for Testing
and Certification (HKCTC) and Hong Kong Accreditation Service (HKAS) co-organized
a seminar entitled “Accreditation for Medical Laboratory – The Road Towards
Quality and Competence” on 12 Oct 2016. Medical
laboratories provide essential support to the medical sector. Accurate and reliable laboratory services are
crucial for proper clinical diagnosis and treatment. It is important for medical laboratories in
Hong Kong to obtain formal recognition of their testing competence and standard
through laboratory accreditation. The seminar
aims to introduce the medical testing accreditation and share the experience of
obtaining accreditation and its benefits.

The first speaker was Ms. Bella Ho (Senior Accreditation
Officer, HKAS) and her topic entitled “Accreditation Service for Medical
Laboratories”. She said the first launch of HOKLAS based on ISO 15189 was on 16
Feb 2004. Before that accreditation was employed
ISO 17025 included NATA. The ISO 15198
Particular requirement for quality and competence of medical laboratories was
published in Dec 2003.

There were six disciplines of
accreditation scope included Anatomical Pathology, Chemical Pathology,
Immunology, Haematology, Microbiology and Medical Genetics. Bella found that no regulatory requirement on
the operation of a medical laboratory. Categories
of accredited laboratory was separated into “P” and “S” according to the whether
the Laboratory Director is a “Pathologist” or a “Scientist”. For approved Signatories, only qualified
pathologists in the relevant pathology discipline can be signatories of these
tests.

It has only regulated the personnel
working in a medical laboratory under the Supplementary Medical Professions
Ordinance (SMPO) (CAP 359) which started from early 1990s. The brief of SMPO is
showed in the following diagram.

Then Bella mentioned some
statistics to us such as total number of medical laboratories accredited since
2004.

And the table of the progress of
the medical programme which included HOKLAS, NATA, and CAP.

Finally, Bella summarized the
changes in the medical testing field after introduction of medical
accreditation programme as follows:

-More educational opportunities,

-More reference resources,

-More platforms for information exchanges.

The second speaker was Dr. QUE
Tak-Lun (Chief of Service, Department of Clinical Pathology, Tuen Mun Hospital)
and his topic named “Benefits of Accreditation to the Community”. Firstly, he shared with us different types of
food he cooked. He said a good cook
depends on cooker, manual, raw material, equipment, etc.

Then he shared the common factors
between Cooker and Pathologist in the following table. Both career should ensure the quality and had
risk management.

At the end, he said accreditation
was not from western. It could be traced
to the first emperor in China.

Before tea break, all guest
speakers took a group photo.

Mr. Stanley Leung (Director of
Clinical Laboratories, Hong Kong Adventist Hospital (HKAH)) was the third
speaker and his topic was “Value of Laboratory Accreditation on Top of Hospital
Accreditation”. Their group had two
hospitals in Hong Kong and they located in Tsuen Wan and Stubbs Road. HKAH-SR specialized in cancer & heart
treatment, and HKAH-TW as a community hospital in Territory West which provided
sub-acute care.

Then Mr. Leung briefed their
history of accreditation included UK, JCI, ACHS, WHO and HOKLAS, etc.

After that Mr. Leung told us the
three criteria, which was focus on Hospital Accreditations, were “Hospital
Safety”, “Staff Competency” and “Overall Quality of Patient Care”. Moreover,
criterial of functions included 1) Clinical, 2) Support and 3) Corporate.

Mr. Stanley Leung mentioned that
most Hospital Accreditation was focused on Blood Bank. Therefore, good blood transfusion practice was
very important.

Finally, he showed the sample
analysis cycle from test ordered to result reported. They got accreditation because of their
values that were Excellence, Service & Care Integrity. He said Laboratory Accreditation (HOKLAS) is
equal to Commitment to Quality.

The fourth speaker was Ms. Cordelia
Leong (Pathology Department Manager, Alice Ho Miu Ling Nethersole Hospital and
North District Hospital) and her topic named “Culture in Laboratory: A Change
After Accreditation”. Firstly, she said
they had many different requirement and systems before laboratory
accreditation. At the time, it was not bad, but greatly depended on a highly
competent leader to put all the things together.

However, accreditation based on
ISO 15189 brought a structured quality management system into the
hospital. It included Management, Man,
Machine, Material and Method requirements as following diagrams.

After accreditation, staff
changed their culture that QMS elements as part of their daily work. The
benefits would be systematic approach, better documentation, traceability,
result accuracy and staff competence, continual improvement and learning
opportunities.

Finally, Ms. Cordelia Leong use
the diagram to explain the Accreditation role from Pull (increase the
management level) before got accreditation and then to be Push (maintenance the
existing level) after accreditation. The
future Pull role is come from “Benefits to the Lab & Staff”.

The last speaker was Mrs.
Marianne Leung (Laboratory Director, Pathlab Medical Laboratories Ltd.) and her presentation topic entitled “How
Accreditation Helps in Business, from a Commercial Laboratory’s View”. Firstly, Mrs. Leung introduced her laboratory
which established since 1975. Now, PathLab has about 140 employees which 50%
technical and 50% auxiliary.

She explained why her laboratory
did accreditation. Because HOKLAS
allowed non-pathologist scientists able to be Lab Directors (S Lab) and staff
morals which was not good / bad but stagnant.
But she quoted “Do something today that your future self will thank you
for.”

Mrs. Leung analyzed areas of business in a commercial laboratory included Internal Problems, Staff Moral & Hiring, New Areas of Business, Reputation and Legal Protection, as well as Business Growth.

Then she explained some internal
problems they had overcome.

A.Pre-analytical

-Phlebotomy side effects and Client’s errors on sample collection &
handling (not labeling tubes, no date or time, name mismatch, no individual
bags, etc.)

B.Analytical

-Multidiscipline MLT Training

C.Reporting

-Signatory duties

D.Management & Business

-Financial matters

Finally, Mrs. Leung concluded
some benefits about accreditation included “Staff Morale and Hiring Ability
Improvement”, “Chance to Bid for New Business – Clinical Trials”, “Better
Reputation & Legal Protection”. At
the end, she showed their lab business growth after accreditation.

Q&A:

During the Q&A, Bella
answered some question about accreditation period and preparation time. She said it was about 10 month after initial assessment
to get the accreditation. For
preparation time, it should be at least from 1 year to 1.5 year to prepare all
documentation.

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作者筆名劍如虹，畢業於香港城市大學及香港理工大學，學術範圍包括應用科學，應用物理，電腦，化學及環境工程等，以業餘時間攻讀完工程管理博士學位。由於喜歡武俠故事式電腦遊戲，才引發奇想，把品質管理理論用武俠小說方式表達。作者現任職品質經理，曾多次於專業學會主辦的國際會議和學術期刊發表論文及研究報告。
Dr. Lotto Lai has 20 year hands-on experience in scientific research, quality assurance and management in Commercial Laboratory, University Testing Centre, Certification Body and Consultants Firm.
He is Former Chairman & Fellow in HKSQ, MHKIE, FASQ, CMQOE and IRCA QMS Lead Auditor, as well as, Asso. Academician in IAQ.